ADVERTISEMENT

Review Pathway

Confirmatory Evidence: Related Indication Must Have A Completed Study That Established Benefit, US FDA Says

Confirmatory Evidence: Related Indication Must Have A Completed Study That Established Benefit, US FDA Says

At the advisory committee review of Stealth’s Barth syndrome treatment elamipretide, Office of New Drugs Director Peter Stein clarified the circumstances where clinical data in a related indication could serve as confirmatory evidence for a single adequate and well-controlled study.

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

PCCPs Can Help Speed Device Sterilization Changes, FDA Webinar Suggests

PCCPs Can Help Speed Device Sterilization Changes, FDA Webinar Suggests

Manufacturers looking to change their device sterilization method as part of the move away from ethylene oxide (EtO) may be able to make use of the Predetermined Change Control Plan (PCCP) process, FDA officials said in a webinar this week.

Janssen’s Nipocalimab Among Six New EU Filings

Janssen’s Nipocalimab Among Six New EU Filings

Nipocalimab is an investigational FcRn blocker for treating generalized myasthenia gravis that was also recently filed for regulatory review in the US.

US FDA’s New Voucher Fee Reveals Standard, Priority Review Cost Spike

US FDA’s New Voucher Fee Reveals Standard, Priority Review Cost Spike

The number of standard and priority reviews also decreased significantly in FY 2023 compared to the previous year, which caused the fee for redeeming a voucher to rise.

US FDA Eager To INTERACT With Start-Ups, Not Check Boxes

US FDA Eager To INTERACT With Start-Ups, Not Check Boxes

A US FDA webinar for start-up sponsors showcased staff who sound enthusiastic about helping drug developers advance their projects, while also emphasizing the importance of early and continual engagement with the agency.

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

Aeon Plans For Next Phase In Bid For Botox Biosimilar

Aeon Plans For Next Phase In Bid For Botox Biosimilar

Aeon Biopharma has heralded its latest interaction with the US FDA over its planned Botox biosimilar as a win that sets the stage for analytical studies, trials and a subsequent filing.

Modernizing Medical Device Design Control: From Waterfalls to a New Landscape

Modernizing Medical Device Design Control: From Waterfalls to a New Landscape

The regulatory, industrial and methodological changes applied to the medtech sector since the introduction of the US Food and Drug Administration’s design control guidance in 1997 are many and varied. Dr. Stuart Grant of Archetype MedTech looks at the challenges these changes present to both innovators and regulators and how the industry needs to adapt.

EMA To Test New Ways Of Managing Conflicts Of Interest

EMA To Test New Ways Of Managing Conflicts Of Interest

The European Medicines Agency is mulling how best to involve experts in its decision-making processes while avoiding potential conflicts of interest, says executive director Emer Cooke.